MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-07-02 for UNKNOWN TED UNK TED manufactured by Covidien, Covidien Mfg.
[3651961]
It was reported to covidien on (b)(4) 2013 that a customer had an issue with a compression stocking. The customer reports the ted caused damage and necrosis to the pt's skin. The pt wore the stocking from 24-48 hours.
Patient Sequence No: 1, Text Type: D, B5
[10880371]
Submit date: (b)(4) 2013. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009211636-2013-00002 |
| MDR Report Key | 3213269 |
| Report Source | 01,06 |
| Date Received | 2013-07-02 |
| Date of Report | 2013-06-06 |
| Report Date | 2013-06-06 |
| Date Reported to Mfgr | 2013-06-06 |
| Date Mfgr Received | 2013-06-06 |
| Date Added to Maude | 2013-07-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN MANUFACTURING SOLUTIONS SA |
| Manufacturer Street | EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN TED |
| Generic Name | COMPRESSION STOCKING |
| Product Code | DWL |
| Date Received | 2013-07-02 |
| Model Number | UNK TED |
| Catalog Number | UNK TED |
| Lot Number | UNK |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, COVIDIEN MFG |
| Manufacturer Address | ALAJUELA 20101 CS 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-07-02 |